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NCT Number: NCT06399198

Three-dimensional Changes in Free Gingival Grafts Around Dental Implants

The purpose of this study is to evaluate the stability of the free gingival graft dimensions around dental implants and to compare three-dimensional changes according to smoking status. Its primary goal is to provide an answer to:

Is this grafting procedure stable around dental implants? Are there any differences in tissue stability between smoker and non-smoker patients?

Our study consists of 2 groups:

The first group includes smoker patients who need free gingival grafts around their dental implants (n=16).

The second group includes non-smoker patients who need free gingival grafts around their dental implants (n=16).

Clinical measurements will be recorded at the baseline, 1st month, 3rd month, and 6th month of the study. An intraoral digital scanner will be used to measure the dimension changes of the graft at the baseline, after the surgery, 1st month, 3rd month, and 6th month of the study. Wound healing will be evaluated on postoperative days 10, 1 month, 3 months, and 6 months. Visual Analog Scale will be used to measure postoperative pain, and the number of painkillers taken will be recorded.

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Key information

Conditions

Insufficient Keratinized Gingiva

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biruni University

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ayşe Ege SELMAN

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Periodontal and peri-implant tissue health
  • Good oral hygiene (plaque accumulation <20%)
  • Either around the functioning implant or in patients scheduled for second-stage surgery following implant surgery <2 mm keratinized gingiva on the vestibular side of the implant
  • No systemic disease and medication use that may affect soft tissue healing.
  • Volunteering to participate in the study

Exclusion criteria

  • Systemic disease that is a contraindication to the surgical procedure,
  • Uncontrolled diabetes (HbA1c > 7),
  • Being pregnant or breastfeeding,
  • Autoimmune and/or inflammatory diseases of the oral cavity,
  • Active periodontal disease,
  • Incorrectly positioned implants

Treatment and study plan

Free gingival graft

Procedure

After adequate local anesthesia is achieved, a horizontal incision will be placed at mucogingival junction level to prepare the recipient bed. A split-thickness flap will be raised without disturbing the periosteum. A free gingival graft will be obtained from the palate. The graft will be shaped and sutured to the recipient surface.

Primary outcomes

  1. The three-dimensional changes of free gingival graft

    Time frame: Baseline

    An intraoral digital scanner will be used to assess the graft's dimensions alterations.

  2. The three-dimensional changes of free gingival graft.

    Time frame: 1st month

    An intraoral digital scanner will be used to assess the graft's dimensions alterations.

  3. The three-dimensional changes of free gingival graft

    Time frame: 3rd month

    An intraoral digital scanner will be used to assess the graft's dimensions alterations.

  4. The three-dimensional changes of free gingival graft

    Time frame: 6th month

    An intraoral digital scanner will be used to assess the graft's dimensions alterations.

Secondary outcomes

  1. Plaque index

    Time frame: Baseline

    0: Absence of microbial plaque

    Thin plaque layer at the mucosal margin, only detectable by scraping with a probe Moderate layer of plaque in the along the mucosal margin; interdental spaces free, but plaque is visible to naked eye Abundant plaque along with the mucosal margin; interdental places filled with plaque

  2. Plaque index

    Time frame: 1st month

    0: Absence of microbial plaque

    Thin plaque layer at the mucosal margin, only detectable by scraping with a probe Moderate layer of plaque in the along the mucosal margin; interdental spaces free, but plaque is visible to naked eye Abundant plaque along with the mucosal margin; interdental places filled with plaque

  3. Plaque index

    Time frame: 3rd month

    0: Absence of microbial plaque

    Thin plaque layer at the mucosal margin, only detectable by scraping with a probe Moderate layer of plaque in the along the mucosal margin; interdental spaces free, but plaque is visible to naked eye Abundant plaque along with the mucosal margin; interdental places filled with plaque

  4. Plaque index

    Time frame: 6th month

    0: Absence of microbial plaque

    Thin plaque layer at the mucosal margin, only detectable by scraping with a probe Moderate layer of plaque in the along the mucosal margin; interdental spaces free, but plaque is visible to naked eye Abundant plaque along with the mucosal margin; interdental places filled with plaque

  5. Gingival Index

    Time frame: Baseline (prior to therapy)

    0: normal gingiva

    mild inflammation - slight change in color and slight edema but no bleeding on probing moderate inflammation - redness, edema and glazing, bleeding on probing severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding

  6. Gingival Index

    Time frame: 1st month

    0: normal gingiva

    mild inflammation - slight change in color and slight edema but no bleeding on probing moderate inflammation - redness, edema and glazing, bleeding on probing severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding

  7. Gingival Index

    Time frame: 3rd month

    0: normal gingiva

    mild inflammation - slight change in color and slight edema but no bleeding on probing moderate inflammation - redness, edema and glazing, bleeding on probing severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding

  8. Gingival Index

    Time frame: 6th month

    0: normal gingiva

    mild inflammation - slight change in color and slight edema but no bleeding on probing moderate inflammation - redness, edema and glazing, bleeding on probing severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding

  9. Bleeding on probing

    Time frame: Baseline

    Bleeding on probing A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth/ implants.

  10. Bleeding on probing

    Time frame: 1st month

    Bleeding on probing A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth/ implants.

  11. Bleeding on probing

    Time frame: 3rd month

    Bleeding on probing A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth/ implants.

  12. Bleeding on probing

    Time frame: 6th month

    Bleeding on probing A bleeding-on-probing percentage score assessed as the proportion of bleeding sites (dichotomous yes/no evaluation) when stimulated by a standardized manual probe with a controlled (~25 g) force to the bottom of the sulcus/pocket at six sites (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual) on all present teeth/ implants.

  13. Keratinized mucosa width

    Time frame: Baseline (prior to therapy)

    The apical-coronal distance from the mucosal margin to the mucogingival junction (MGJ) Measurements will be made at three points on implants (mesiobuccal, midbuccal, distobuccal) using a periodontal probe.

  14. Keratinized mucosa width

    Time frame: 1st month

    The apical-coronal distance from the mucosal margin to the mucogingival junction (MGJ) Measurements will be made at three points on implants (mesiobuccal, midbuccal, distobuccal) using a periodontal probe.

  15. Keratinized mucosa width

    Time frame: 3rd month

    The apical-coronal distance from the mucosal margin to the mucogingival junction (MGJ) Measurements will be made at three points on implants (mesiobuccal, midbuccal, distobuccal) using a periodontal probe.

  16. Keratinized mucosa width

    Time frame: 6th month

    The apical-coronal distance from the mucosal margin to the mucogingival junction (MGJ) Measurements will be made at three points on implants (mesiobuccal, midbuccal, distobuccal) using a periodontal probe.

  17. Probing depth

    Time frame: Baseline

    Probing pocket depth: The distance from the base of the pocket to the mucosal margin. Measurements will be made at six points on all teeth/ implants (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe.

  18. Probing depth

    Time frame: 1st month

    Probing pocket depth: The distance from the base of the pocket to the mucosal margin. Measurements will be made at six points on all teeth/ implants (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe.

  19. Probing depth

    Time frame: 3rd month

    Probing pocket depth: The distance from the base of the pocket to the mucosal margin. Measurements will be made at six points on all teeth/ implants (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe.

  20. Probing depth

    Time frame: 6th month

    Probing pocket depth: The distance from the base of the pocket to the mucosal margin. Measurements will be made at six points on all teeth/ implants (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual) using a periodontal probe.

  21. Wound healing

    Time frame: 10th day

    Presence of infection (yes/no), soft tissue dehiscence (yes/no), and graft failure (yes/no) will be recorded.

  22. Wound healing

    Time frame: 1st month

    Presence of infection (yes/no), soft tissue dehiscence (yes/no), and graft failure (yes/no) will be recorded.

  23. Wound healing

    Time frame: 3rd month

    Presence of infection (yes/no), soft tissue dehiscence (yes/no), and graft failure (yes/no) will be recorded.

  24. Wound healing

    Time frame: 6th month

    Presence of infection (yes/no), soft tissue dehiscence (yes/no), and graft failure (yes/no) will be recorded.

  25. Patient reported outcomes

    Time frame: 10th day

    After the surgical procedure, patients will be asked to complete a form consisting of 4 items: (1) assessment of the intensity of postoperative pain/discomfort (by Visual Analog Scale), (2) duration of pain (in days), (3) number of analgesic tablets taken, and (4) willingness to undergo the same surgery again (yes/no).

Study contacts

Contact information is provided by the study sponsor or research team.

Ayse E Selman

CONTACT

[email protected]

+905366393184

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Registry information

Official study title

Evaluation of the Three-dimensional Changes in Free Gingival Grafts Around Dental Implants

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 3, 2024
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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